Sr Clinical Research Associate

JOB SUMMARY

The Sr. CRA is responsible for assisting with operational activities that support clinical trial administration and progress, with a focus on study oversight and clinical site management. This position works closely with a cross-functional team, vendors, sites, and CRO to ensure compliance with the protocol and the overall clinical trial objectives. The Sr. CRA may assist in program level status tracking and reporting across multiple studies. Additionally, this role will be responsible for implementing and monitoring clinical study activities to assure adherence to good clinical practices (GCPs) and standard operating procedures (SOPs).

The Sr. CRA must adhere to the company’s core values and comply with all applicable regulations, ICH-GCP guidelines, and SOPs. Strong candidates should have a solid understanding of trial and study site management, vendor management, and experience participating in the full cycle of studies from start-up to close-out. This role will report to the Director of Clinical Operations and is based in San Diego, CA.

KEY RESPONSIBILITIES

• Oversees aspects of study management and vendors (e.g. IRT, cardiac safety, patient reimbursement vendors) to ensure high quality of data and to ensure study execution and deliverables are met with minimum supervision

• Overall management of selected clinical sites including acting as a point of escalation and oversight of CRO monitoring activities, which includes monitoring visit report review, contract and budget negotiations with clinical sites. Assists with shipment and reconciliation of Investigational Product (IP) at study and site level as needed.

• Assists the Study Lead or independently provides Sponsor oversight of CRO, including study-specific documentation review and QC, and reviews of ICFs, study plans, study reference manuals, eCRFs, etc.

• Assist with creation and maintenance of study metrics trackers, tools and reports

• Assists the Study Lead or independently provides Sponsor oversight of CRO-held eTMFs, including periodic audit and findings resolution

• Assists with customization of CDA, clinical site contract & budget templates, when applicable

• Assists the clinical team with coordination of Investigator Meetings and direct KOL/PI interactions, including meeting preparation and generation of minutes

QUALIFICATIONS

• Bachelor's Degree or equivalent international degree

• 4 or more years or experience in pharmaceutical industry, clinical research organization (CRO), or related role; CRO experience preferred

• Experience working on Phase 1 and 2 studies and global/international studies is advantageous

• Experience and knowledge of ICH GCP, eTMF management and DIA TMF Reference Model

• Excellence in task management and collaboration

• Proficient in English language (spoken and written)

ABOUT IAMBIC THERAPEUTICS

Founded in 2019 and headquartered in San Diego, California, Iambic Therapeutics is disrupting the therapeutics landscape with its unique AI-driven drug-discovery platform. Iambic has assembled a world-class team that unites pioneering AI experts and experienced drug hunters with strong track records of success in delivering clinically validated therapeutics. The Iambic platform has been demonstrated to deliver high-quality, differentiated therapeutics to clinical stage with unprecedented speed and across multiple target classes and mechanisms of action. The Iambic team is advancing an internal pipeline of clinical assets to address urgent unmet patient needs. Learn more about the Iambic team, platform, and pipeline at iambic.ai.

MISSION & CORE VALUES

The culture and work at Iambic Therapeutics are profoundly strengthened by the diversity of our people and our differences in background, culture, national origin, religion, sexual orientation, and life experiences. We are committed to building an inclusive environment where a diverse group of talented humans work together to discover therapeutics and create technologies.

PAY AND BENEFITS

We offer industry leading competitive pay, company paid healthcare, flexible spending accounts, voluntary life Insurance, 401K matching, and uncapped vacation to our team. We are in a brand-new state-of-the art facility in beautiful San Diego with an onsite gym, dining, and easy access to great places to live and play.